印度医药产业的发展及对我们的启示

印度在药品研发、生物技术和化学制药等方面具有相当可观的合作潜力和境外研发潜力。2004年印度医药市场价值约为51亿美元。从药品金额来看,印度医药市场占全球医药市场的1％,名列全球第13位;从药品用量来看,印度医药市场占全球医药市场的8％,名列全球第4位。在过去30年间,印度仿制药的市场份额一直保持在很高的水平,无论从技术含量、产品质量还是产品种类来说,印度制药行业都处于比较领先的地位。同印度相比,中国在人口、经济状态等方面都较相像,所以印度企业取得的成就,值得我国同行借鉴。     

1993年武汉市医药市场浅析

1992年全国医药商品货源充足,价格平稳,新药走俏,医药市场仍保持较好的增长势头。1993年医药市场面临的形势是,国家指令性计划取消,商品将根据市场调节,药品专利实施,关贸总协定执行,进口药品(特别是进口制剂)、中外合资药品增长幅度将冲击我国的药品市场,对工厂企业将会带来严峻的考验。公费医疗制度的改革给医院的收入和药品使用结构方面带来一些影响。就去年全国药品供销情况来看,对1993年武汉医药市场有以下几点分析:     

当前生物技术药物及其开发趋势

本文对当前国内外生物技术药物的结构现状、医药生物技术的应用及特点进行了讨论,同时对今后生物技术药品的发展趋势也进行了探讨。     

加强药品监管工作促进医药流通改革和药品零售经营连锁化

国家药品监督管理局（ＳＤＡ）是国务院负责对药品的科研、生产、流通、使用进行监管的职能部门。药品监督管理与医药流通改革有着密切的关系。作为政府的一个职能部门,药品监督管理部门有责任和义务通过改革和加强药品监督管理工作为医药流通体制改革工作的顺利进行创造良好的法律、政策环境和市场环境。一、医药流通领域的现状据分析测算,２０００年全国药品市场消费总额为１０００多亿元,人均药品消费８０元左右。目前,我国医药商业企业有职工５０多万人,药品批发企业及网点１６５００多个,药品零售企业及网点近１２万个,医药商业…     

我国人用生物制品的概况

随着现代生物技术向我国医药企业的广泛渗透 ,以基因工程 ,细胞工程 ,发酵工程和蛋白质工程为基础技术的生物制品已成为一门独立科学和新兴产业 ,迄今我国已有数百家生物技术公司 (厂家 )参与生物制品的研发 ,使得生物制品成为近年来发展最快的高新技术产业之一 ,在整个医药市场中的份额 ,不断攀升 ,市场竞争亦很激烈。1　生物制品的定义生物制品是应用普通的或以基因工程、细胞工程、蛋白质工程、发酵工程等生物技术获得的微生物、细胞及各种动物和人源的组织和液体等生物材料制备 ,用于人类疾病预防、治疗和诊断的药品。我国人用生物制品…     

生物技术医药产品开发和市场分析

本文综述了国内、国外生物技术医药产品研究和市场情况。在医药生物技术研究方面往往处于领先地位的美国在开发新药市场方面却落后于欧洲，以此为鉴，作者提出根据国情如何加快中国的生物技术医药产品的市场开发是一个值得重视的课题。     

CRO敛金中国药研市场

<正> ●全球医药企业及时挖掘中国市场的优势,在不断争抢医药研发领域的无限商机●目前,众多新兴生物技术公司开始投入对新药的研发●与CRO一同到来的将是中国医药经济明天的辉煌继诺和诺德之后,仅仅几年时间,阿斯利康、礼莱、施维雅和罗氏等跨国药企纷纷在中国设立研发中心。中国研发市场正以人力资源丰富、价廉物美显露出巨大的发展潜力。其实,在跨国医药企业登陆之前,CRO已作为新兴淘金链的一环,分享着药品研发的丰厚利益。研发已成为医药企业利润扩张的发动机。近20多年来,以提供药品研发专业技术为盈利模式的     

国家医药管理局局长郑筱萸指出要加强医药流通体制改革

国家医药管理局局长郑筱萸在全国医药管理局长会议上强调,要把医药流通体制改革作为1997年的一项重点工作来抓,积极培养和开拓医药市场。 他指出,今年医药管理部门将与有关部门密切合作,进一步开展治理整顿医药市场工作,下决心继续抓紧抓好下一阶段药品购销中给予、收受回扣违法行为专项检查工作,在深化医药流通体制改革中规范药品市场行为,确保整治工作取     

药品零售业管理的问题与对策

零售药房是我国药品流通领域的一个重要环节 ,也是医药市场的主要组成部分。零售药房直接面对着广大药品消费者 ,在丰富医药市场 ,方便人民用药 ,促进药品销售方面起着重要作用。因此在我国颁布新修订的《药品管理法》、《城镇职工基本医疗保险定点零售药店管理暂行办法》 ,《零售药店设置暂行规定》、《药品零售连锁企业有关规定》、《处方药与非处方药管理办法》等法律、法规中 ,对规范药品零售企业都做出了相应的规定。 2 0 0 3年我国将开放药品分销服务 ,许多国外的经销商将进入国内医药市场 ,这将给我国药品零售业带来前所未有的竞争与…     

生物制药产业的发展及药品生物的测定

现代生物技术医药产业化进程：我国自80年代开始进行现代生物技术药品的研究和开发,虽然起步较晚,基础较差,但一开始就受到党和国家的高度重视,并列为“863”计划和国家重点攻关项目的主要内容,经过多午的努力,现代生物技术医药产业有了突破性的进展,到1998年7月底我国已有十四种现代生物技术药品和疫苗投入生产。     

Nanomedicine: clinical applications of polyethylene glycol conjugated proteins and drugs

The intricate problems associated with the delivery and various unnecessary in vivo transitions of proteins and drugs needs to be tackled soon to be able to exploit the myriad of putative therapeutics created by the biotechnology boom. Nanomedicine is one of the most promising applications of nanotechnology in the field of medicine. It has been defined as the monitoring, repair, construction and control of human biological systems at the molecular level using engineered nanodevices and nanostructures. These nanostructured medicines will eventually turn the world of drug delivery upside down. PEGylation (i.e. the attachment of polyethylene glycol to proteins and drugs) is an upcoming methodology for drug development and it has the potential to revolutionise medicine by drastically improving the pharmacokinetic and pharmacodynamic properties of the administered drug. This article provides a total strategy for improving the therapeutic efficacy of various biotechnological products in drug delivery. This article also presents an extensive analysis of most of the PEGylated proteins, peptides and drugs, together with extensive clinical data. Nanomedicines and PEGylation, the latest offshoots of nanotechnology will definitely pave a way in the field of drug delivery where targeted delivery, formulation, in vivo stability and retention are the major challenges.     

生物技术药物药代动力学研究进展

生物技术药物作为现代药物研发热点而备受关注,它具有和传统小分子药物截然不同的理化性质,因此其药动学呈现出独特性和复杂性。阐述生物技术药物的概念;总结4种主要的生物技术药物分析方法;进一步综述生物技术药物在体内吸收、分布、代谢和排泄的药动学特点;最后以生物技术药物主流之一的单克隆抗体药物为代表,通过相关数据对比单克隆抗体药物与传统小分子药物在药动学方面的差异。以期为充分了解生物技术药物的药动学特征以及形成机制、研发和筛选新型生物技术药物提供强有力的支持,同时为药物安全性评价和临床用药提供重要参考。     

Biopharmaceutics and pharmacokinetics in drug research

With the synergistic and multiplicative interactions of rational drug design, recombinant biotechnology, combinatorial chemistry and high-throughput screening, millions of compounds are being synthesized by chemists. However, development of these drug candidates has often been impeded, if not terminated, due to biopharmaceutic and/or pharmacokinetic constraints. This has resulted in delays in development time and escalation of cost in the drug research programmes. So, the present emphasis is to reduce development time and cost, which is analogous to added patent life besides the enormous reduction in human suffering. In this compilation the important biopharmaceutic and pharmacokinetic approaches are discussed, which will help in the development of safe and more efficacious drugs with reduced development time and cost.     

The importance of new companies for drug discovery: origins of a decade of new drugs

Understanding the factors that promote drug innovation is important both for improvements in health care and for the future of organizations engaged in drug discovery research and development. By identifying the inventors of 252 new drugs approved by the US Food and Drug Administration from 1998 to 2007 and their places of work, and also classifying these drugs according to innovativeness, this study investigates the contribution of different types of organizations and regions to drug innovation during this period. The data indicate that drugs initially discovered in biotechnology companies or universities accounted for approximately half of the scientifically innovative drugs approved, as well as half of those that responded to unmet medical needs, although their contribution to the total number of new drugs was proportionately lower. The biotechnology companies were located mainly in the United States. This article presents a comprehensive analysis of these data and discusses potential contributing factors to the trends observed, with the aim of aiding efforts to promote drug innovation.     

Iconix Biosciences, Inc

Iconix Biosciences has developed leading products and services that apply novel and proprietary genomic technologies to profile candidate drug compounds in early discovery through to preclinical development, leading to a better understanding of candidate drugs in a faster, more cost-effective manner. The toxicology community is embracing this approach to increase the accuracy, sensitivity and speed of toxicity testing. Changing this paradigm will significantly impact the failure rate of late-stage preclinical compounds and provide a compelling return on investment. Through strategic growth and research, the company has identified the factors and is creating the environment that will lead to a 'tipping point' in the pharmaceutical and biotechnology industries, such that toxicogenomics becomes a standard practice in the drug discovery and development process.     

Investigational drug tracking: phases I-III and NDA submissions--Part II

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. Part I of this article appeared in the September issue of Hospital Pharmacy. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I concludes with the remaining alphabetical listing by generic/chemical name or investigational drug number.     

Investigational drug tracking: Phases I-III and NDA submissions--Part I

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I includes the trade name and synonym cross-indexes and the beginning of the main alphabetical listing by generic/chemical name or investigational drug number.     

The impact of nanobiotechnology on the development of new drug delivery systems

Nanotechnology, or systems/devices manufactured at the molecular level, is a multidisciplinary scientific field undergoing explosive development. A part of this field is the development of nanoscaled drug delivery devices. Nanoparticles have been developed as an important strategy to deliver conventional drugs, recombinant proteins, vaccines and more recently nucleotides. Nanoparticles and other colloidal drug delivery systems modify the kinetics, body distribution and drug release of an associated drug. Other effects are tissue or cell specific targeting of drugs and the reduction of unwanted side effects by a controlled release. Therefore nanoparticles in the pharmaceutical biotechnology sector improve the therapeutic index and provide solutions for future delivery problems for new classes of so called biotech drugs including recombinant proteins and oligonucleotides. This review discusses nanoparticular drug carrier systems with the exception of liposomes used today, and what the potential and limitations of nanoparticles in the field of pharmaceutical biotechnology are.     

The biotechnology era: has the promise been fulfilled?

Biotechnological advances have changed the traditional landscape of the drug discovery process. Mutually beneficial relationships between small, innovative and nimble biotechnology companies and experienced, well-funded pharmaceutical companies have resulted in a more rapid application of new technologies to drug development and diversification. Protein-based drugs, such as therapeutic monoclonal antibodies, exemplify the fulfillment of the promise of the biotechnology revolution.     

Antiretroviral drug development for HIV: challenges for the future

The scarcity of new innovative drugs in the development pipeline for combating HIV replication may signal a change in direction for HIV researchers and drug developers. The model of introducing drugs with incremental improvements within existing drug classes is no longer commercially viable. While an argument can be made that drugs aimed at novel targets may have a greater impact, the list of such targets is limited and the scientific challenge of intervening at another stage in the HIV replication cycle is high. It is difficult to envision a realistic risk/reward scenario that will ensure continued investment in the discovery of novel HIV drugs that simply block replication and suppress plasma viral load. Recently, it has been suggested that the scientific community should move research in a new direction, with the goal of attacking the reservoirs of latent HIV that persist despite treatment with current drugs to achieve a functional cure, if not a sterilizing cure. This process will have to be a long-term commitment, primarily funded by the NIH, with some involvement by the pharmaceutical and biotechnology industries. While most individuals infected with HIV can achieve viral suppression with the current approved therapies, treatment is lifelong, side effects are significant and resistance will eventually render more of these drugs less effective. New and innovative approaches must be developed to prevent viral infection and further improve the quality of life for those individuals who are already infected.